Pharmaceutical, Biotechnology, Bio-Pharmaceutical, Medical Device Companies and academic researchers conduct clinical studies to evaluate the safety and efficacy of new products to help determine suitability for the market. These groups or companies are known as Clinical Trial Sponsors. An important part of the clinical study is to collect a variety of clinical data on patients to test the product in a controlled setting. These data are typically presented by the Sponsor in a variety of formats including various statistical analyses to the appropriate regulatory agencies, such as the Food and Drug Administration for review and approval.
A clinical study team can be comprised of many individuals, from many organizations, and from many countries. In addition to the Sponsor, there is usually a group, or groups, tasked with conducting the study on behalf of the Sponsor. These groups are known as Clinical Research Organizations (CROs). In addition to the Sponsor and CROs, the study employs Clinical Sites (Site) which are managed by physicians, known as the Principal Investigator (PI). Sites are typically located at doctors' offices, hospitals or clinics, depending upon the therapeutic area of the study itself. Each Site will recruit and enroll patients into the study until the number of patients required for the appropriate statistical analyses has been reached. The larger the study and the more countries involved, the more staff will be required. The number of Sites and CROs required to conduct the study may also be larger.
The integrity of the data collected in the study is paramount to the success of the study. The staff of the Sites, as defined by the Sponsor, must carefully execute the clinical protocol. All data must be properly recorded in compliance with Good Clinical Practice (GCP) policy, as well as other local and global regulations for study conduct. In order to ensure data integrity and regulatory compliance, personnel are dispatched to the Sites to review clinical data, protocol compliance, and regulatory compliance. These personnel are known as Study Monitors (Monitors) or Clinical Research Associates (CRA). Any monitor can make several trips to their Site during the course of the study. During each visit, the monitor checks various electronically entered clinical data against their source sheets for accuracy. The monitor can then either accept the Case Report Form (CRF) if there have been no discovered discrepancies, or create a query where an inconsistency occurs. The time that monitors spend at a site is very limited. Thus, having a focused plan of action to review outstanding data issues saves valuable time. Monitors often have no way to know what data-related issues may exist, and must perform quite a bit of discovery once they arrive at the site.
Locking a clinical database is essentially freezing all entry or changes to data once the data has been reviewed and accepted by the clinical team working on the study. This can be a laborious and time-consuming process that can have many stages of lock. Soft lock of a database typically includes a subset of the overall database made up of the key efficacy and safety data points. A hard lock typically includes all of the data points in the database. An interim lock includes a subset of the database up to a certain number of patients reaching a certain time point in the study. There are many steps in the lock process that can delay the process of collecting, cleaning and verifying the accuracy of the data. These include data entry into the CRF, having the CRF signed by the site personnel, having the CRF data reviewed by the CRA for accuracy, the CRA locking the CRF, and coding the data into standard dictionaries. The traditional process for these activities takes a significant amount of time, since tracking the status of each activity as it occurs is a major challenge.
The impact on patient heath is also compromised by product approval delays. Such result in important treatments not yet being available to patients who need them. The business impact on these delays is also significant. The longer it takes to complete the analysis of the study data, the longer it takes to get the product to market. Each month of delay could cost the sponsor hundreds of millions of dollars in revenue at the time the product is at peak sales on the market.
Accordingly, there is an unmet need for methods and systems that can speed up the database locking process. The present invention fulfills such a need.